Endocrowns as Permanent Restorations for Endodontically Treated Permanent Molars in Young Age: Two-Year Follow up

NCT ID: NCT04511117

Last Updated: 2021-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2021-11-01

Brief Summary

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Background: A real challenge faces practitioners in dealing with permanent molars in young patients starting from proper selection of endodontic treatment system till the type of final coronal restoration. For permanent molars in young age patients, which system should be followed to guarantee better performance and enhance the integrity of such weakened teeth? The question most commonly asked.

Purpose: To evaluate two-year clinical performance of endocrowns as permanent restorations for endodontically treated molars in young age.

Detailed Description

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Endodontic treatment will be done for all patients using ProTaper Next rotary files and iRoot SP sealer. Then patients were randomly divided into two groups;

Gr 1: Conventional group (CG), the coronal cavity will be restored directly with bulk-fill nanohybrid composite restorations.

Gr 2: Endocrown group (EG), the coronal cavity will be restored with IPS e.max CAD endocrown restorations.

* First step: Endodontic treatment protocol will be used as the following:

1. Biomechanical preparation using; 2.6% NaOCl for irrigation, ProTaper Next rotary files for instrumentation and 17% EDTA gel for lubrication.
2. Obturation of root canal using; ProTaper gutta-percha and iRoot SP sealer.
* Second step: Endocrown restoration protocol will be used as the following:

1. Occlusal Butt joint design for Endocrown preparation.
2. Putty-wash technique for taking impression.
3. IPS e.max CAD for Endocrown construction.
4. G-CEM self-adhesive resin cement for Endocrown cementation.
* Follow up visits: The patients will be recalled every 6 months for evaluation.
* Evaluation methods:

* Endodontic treatment evaluation: The outcome will be evaluated clinically and radiographically.
* Endocrown restoration evaluation: The outcome will be evaluated clinically in terms of; marginal adaptation, marginal discoloration and surface alteration.

Conditions

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Endodontically Treated Teeth Permanent Molars

Keywords

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Endocrown, Monoblock restoration, Endodontically treated teeth Young age

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Control group: the patient will receive direct composite resin restorations. Endocrown group: the patient will receive endocrown restorations.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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Control Group

ProTaper Next rotary system and iRoot SP sealer will be used for root canal treatment, followed by composite restorations.

Group Type ACTIVE_COMPARATOR

Control group

Intervention Type OTHER

ProTaper Next rotary system and iRoot SP sealer with composite restorations.

Endocrown Group

ProTaper Next rotary system and iRoot SP sealer will be used for root canal treatment, followed by endocrown restorations.

Group Type EXPERIMENTAL

Endocrown group

Intervention Type OTHER

ProTaper Next rotary system and iRoot SP sealer with endocrown restorations.

Interventions

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Control group

ProTaper Next rotary system and iRoot SP sealer with composite restorations.

Intervention Type OTHER

Endocrown group

ProTaper Next rotary system and iRoot SP sealer with endocrown restorations.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Patients were systemic free.
2. Mature lower permanent first molar needs conventional endodontic treatment.
3. The remaining coronal tooth structure after endodontic treatment is not less than 50%.
4. Presence of teeth in opposite arch with normal occlusion.
5. Absence of para-functional habits.
6. Supra-gingival margin after preparation.
7. No known allergies.
8. Complaint patient (parent/ guardians)

Exclusion Criteria

1. Immature lower permanent first molar.
2. Presence of teeth, whose coronal anatomy does not allow use of rubber dam for optimum bonding.
3. Lack of cooperation of the patients to perform a postoperative radiograph and use a rubber dam for bonding.
Minimum Eligible Age

9 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Roqaia Mohammad Alassar

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Roqaia M Alassar, DDS

Role: PRINCIPAL_INVESTIGATOR

Fixed Prosthodontist, Faculty of Dental Medicine for Girls, Al-Azhar University

Heba Abdelkafy, DDS

Role: PRINCIPAL_INVESTIGATOR

Endodontist, Faculty of Dental Medicine for Girls, Al-Azhar University

Eman Abdelraouf, DDS

Role: PRINCIPAL_INVESTIGATOR

Pedodontist, Faculty of Dental Medicine for Girls, Al-Azhar University

Locations

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Faculty of Dental Medicine for Girls, Al-Azhar University

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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PD-P-019-002

Identifier Type: -

Identifier Source: org_study_id